Quality Assurance Associate at Stryker

St Leonards, Victoria, Australia

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Working knowledge of regulatory frameworks and legislation in Australia and New Zealand
Experience analyzing and interpreting regulatory documentation
Strong time management and planning skills
Effective communication and stakeholder engagement abilities
Ability to build relationships across diverse teams
Receptive to feedback and committed to personal growth
Detail-oriented problem-solver with great attention to detail, curiosity, and strong ability to develop meaningful relationships quickly
Thrive in complex, layered environments, enjoy collaborative work, and have a knack for translating complex concepts into practical business processes
Proactive, analytical, and committed to continuous improvement
Preferred Experience
Prior experience in regulatory affairs or quality assurance
Experience in a regulated industry, ideally medical devices
Familiarity with Australian and international medical device regulations
Tertiary qualifications in science, engineering, or a related field

Responsibilities

Own and manage QMS processes in accordance with ISO 13485 and regulatory standards
Act as a key contact for quality issues across SSP and global teams
Represent Stryker in internal and external audits
Lead and support Change Control, Nonconformances (NCs), and Corrective and Preventive Actions (CAPAs)
Train and coach SSP personnel on quality processes and regulatory obligations
Maintain and update standard operating procedures and ensure compliant record keeping and documentation
Drive process improvement initiatives and stay informed on regulatory changes and educate

Skills

Key technologies and capabilities for this role

ISO 13485QMSCAPAChange ControlNonconformancesAuditsSOPRegulatory ComplianceProcess Improvement

Questions & Answers

Common questions about this position

What work arrangement does this role offer?

The role offers a hybrid work flexibility.

What are the required skills for this Quality Assurance Associate position?

Required skills include working knowledge of regulatory frameworks in Australia and New Zealand, experience analyzing regulatory documentation, strong time management and planning skills, effective communication and stakeholder engagement, and ability to build relationships across diverse teams.

What is the company culture like at Stryker South Pacific?

The culture emphasizes quality as partnering rather than policing, highly collaborative work across departments like Sales, Marketing, Regulatory, Service, and Operations, and driving a quality-first mindset for patient safety and regulatory excellence.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What makes a strong candidate for this position?

Strong candidates are detail-oriented problem-solvers with great attention to detail, curiosity, ability to develop relationships quickly, thrive in complex environments, enjoy collaboration, translate complex concepts into practical processes, and are proactive, analytical, and committed to continuous improvement.

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees